Telepharmacy Pilot Project Proposal 1. Scope - Mission of pilot 2. Proposed Locations - Locations to be included in the Pilot project 3. Background - A brief description, narrative, or summary of the new process or procedure for which approval is being sought. 4. Waivers - A listing of the laws or regulations for which waivers are being requested through approval of this pilot program. 5. Objectives - An explanation as to the rationale and objectives for the program 6. Outcomes - A summary of outcomes which will be measured, method for measuring, and timelines for measurements and reporting to the Board 7. Security - Any measures which will be taken to ensure security of drug product and Confidential/HIPAA information in the execution of the pilot program. 8. Disclosure - Disclosure of any financial interests, if applicable. 9. Appendix - Any additional supporting information, such as technical or other descriptive literature describing equipment or a process, or information from another state where this process or procedure has been tested. a. See policies & procedures in Exhibit A b. See supporting studies & resources in Exhibit B c. See telepharmacy application information in Exhibit C d. See letters of support in Exhibit D e. See description of Prescription Shop in Exhibit E f. See description of Self Inspection Report in Exhibit F g. See proposed Telepharmacy Rules in Exhibit G h. See proposed pharmacy layout in Exhibit H Next Texas Administrative Code Rule>> TITLE 22 EXAMINING BOARDS PART 15 TEXAS STATE BOARD OF PHARMACY CHAPTER 291 PHARMACIES SUBCHAPTER ALL CLASSES OF PHARMACIES A RULE §291.23 Pilot or Demonstration Research Projects for Innovative Applications in the Practice of Pharmacy (a) Purpose. The purpose of this section is to specify the procedures to be followed in applying for approval of a pilot or demonstration research project for innovative applications in the practice of pharmacy as authorized by §554.011 of the Texas Pharmacy Act (Chapters 551- 566 and 568 - 569, Texas Occupations Code). In reviewing projects, the board will only consider projects that expand pharmaceutical care services which contribute to positive patient outcomes. The board will not consider any project intended only to provide a competitive advantage. (b) Scope of pilot or demonstration research projects and the board's approval of such projects. (1) Pilot or demonstration research projects may not: (A) expand the definition of the practice of pharmacy as provided in the Act; or (B) include therapeutic substitution or substitution of medical devices used in patient care. (2) The board's approval of pilot or demonstration research projects may include the granting of an exception to the rules adopted under the Texas Pharmacy Act, but may not include an exception from any law relating to the practice of pharmacy. Such exception to the rules shall be for a specified period of time and such period may not exceed 18 months. (3) The board may extend the time an exception to a rule is granted as necessary for the board to adopt an amendment or modification of the rule. (c) Procedures for applying for approval of pilot or demonstration research projects. A person who wishes the board to consider approval of a pilot or demonstration research project shall submit to the board a petition for approval which contains at least the following information: (1) name, address, telephone number, and pharmacist's license number of the pharmacist responsible for overseeing the project; (2) specific location and, if a pharmacy, the pharmacy license number where the proposed pilot or demonstration project will be conducted; (3) a detailed summary of the proposed pilot or demonstration project which includes: (A) the goals, hypothesis, and/or objectives of the proposed project; (B) a full explanation of the project and how it will be conducted; (C) the time frame for the project including the proposed start date and length of study. Such time frame may not exceed 18 months; (D) background information and/or literature review to support the proposal; (E) the rule(s) that will have to be waived in order to complete the project and a request to waive the rule(s); (F) procedures to be used during the project to ensure that the public's health and safety are not compromised as a result of the rule waiver. (d) Review and approval or denial of the proposed projects. (1) On receipt of a petition for approval of a pilot or demonstration research project, board staff shall initially review the petition for completeness and appropriateness. If the petition is incomplete or inappropriate for board consideration for any reason, staff shall return the petition with a letter of explanation. Such review shall be completed within 30 working days of receipt of the petition. (2) Once board staff has determined that the petition is complete and appropriate, a task force composed of board staff, at least one board member and, if deemed necessary, resource personnel appointed by the board president, shall review the petition and make a written recommendation to the board regarding approval. Such recommendation shall be presented to the board at the next regularly scheduled meeting of the board that occurs at least three weeks after completion of the review and written recommendation. (3) A copy of the recommendation shall be provided to the petitioner and the board at least two weeks prior to the board meeting. (4) Both the petitioner and a representative of the task force shall be given equal time for presentations to the board. (5) Upon hearing the presentations, the board shall either approve or deny the petition. If the board approves the petition, the approval: (A) shall be specific for that project and for a specific time period; and (B) may include conditions or qualifications, if deemed appropriate by the board. (6) The board or its representatives shall be allowed to inspect and review the project documentation and site at any time during the review process and after the project is approved. (e) Presentation of results to the board. (1) The pharmacist responsible for overseeing the project shall forward to the board a summary of the results of the project and conclusions drawn from the results within three months after completion of the project. (2) A task force composed of board staff, at least one board member and, if deemed necessary, resource personnel appointed by the board president, shall review the results and make written recommendations to the board regarding the results of the project. (3) The board will receive the report of the task force at the next regularly scheduled meeting of the board that occurs at least three weeks after the task force has completed its review and issued written recommendations. (4) A copy of the task force recommendation shall be provided to the petitioner and the board at least two weeks prior to the board meeting. (5) Both the petitioner and a representative of the task force shall be given equal time for presentations to the board. Scope - Modify current regulation 291.121(c) to eliminate some of the barriers to allow the provision of pharmacy services through the use of a telepharmacy system. This will allow our pharmacy to to expand pharmaceutical care services which contribute to positive patient outcomes. Proposed Location - Telepharmacy #1 Pharmacist in-charge: Micah Pratt Pharmacy Address: 524 8th St, Olton, TX 79064 Telephone Number: TBD Pharmacy License Number: TBD Description of location: Olton Clinic is a rural health clinic who recently was purchased by Lamb Healthcare Center (county own hospital - Lamb County) Closest Pharmacy - Prescription shop 30 miles, or pharmacies in Plainview,tx 30 miles Telepharmacy #2 Pharmacist in-charge: Micah Pratt Proposed Pharmacy Address: 201 E Grant Ave, Morton, TX 79346 (Cochran Memorial Hospital or Morton rural health clinic) Telephone Number: TBD Pharmacy License Number: TBD Description of location: This location use to have a pharmacy but no more. They do have a hospital and clinic. They are considered a rural indigent county like Lamb County Closest Pharmacy - 37 miles from Prescription Shop and 28 miles from levelland, Tx Host Pharmacy - Pharmacist in-charge: Micah Pratt Pharmacy Address: 1506 A South Sunset, Littlefield, Tx 79339 Telephone Number: 806-385-4491 Pharmacy License Number: 27958 Background In Texas, there are 149 communities (177,598 residents) that have to travel 10 miles or more to the nearest pharmacy, and according to the US Department of Health and Human Services, 1,146 areas that have a shortage of health care professionals.. Access to a pharmacist has been shown to be highly effective in improving outcomes1, and the closing of rural pharmacies is having a devastating effect on these critical services for Texas residents living in rural areas. Seventy-seven percent of rural counties in the United States are designated as primary care health professional shortage areas. Residents in these areas, typically elderly, have to travel long distances to pick up their prescription medications and see their pharmacist. These patients already face a number of challenges related to healthcare services close to home, including weather, geography, and social barriers. Patients see their pharmacist more often than any other healthcare professional2, so making them more readily available should be a top priority. Studies have been done to evaluate factors that contribute to decreased medication adherence; lack of access to healthcare services and prescribers has been listed as a top cause. Additionally, patients have described difficulties in receiving medication refills often leading to gaps in therapy when access to a healthcare provider is limited.3 Medication nonadherence contributes to increased costs to taxpayers and health systems due to poor outcomes, hospital readmissions, and unnecessary doctor visits. By eliminating the barrier to accessible pharmacy services and increasing rural access to a pharmacist, there is an opportunity to decrease state healthcare costs, while improving patient outcomes.